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NCT06786325 · ClinicalTrials.gov registry record · Phase 2
Wellcome Leap Psilocybin for OUD
A Phase 2 study of Opioid Use Disorder, sponsored by Anna Rose Childress, Ph.D..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06786325: Recruiting Phase 2 study of Opioid Use Disorder, sponsored by Anna Rose Childress, Ph.D..
NCT06786325 is a Phase 2 study of Opioid Use Disorder that is actively recruiting participants, run by Anna Rose Childress, Ph.D.. The registered enrollment target is 36 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06786325, a Phase 2 study of Opioid Use Disorder, is actively recruiting participants, sponsored by Anna Rose Childress, Ph.D..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Investigators will recruit 36 individuals on MAT for OUD for a double-blind, placebo-controlled design to determine whether PEX010 (25-mg/d) shows preliminary efficacy on neural correlates of neurocognition and on clinical outcomes. Participants will be randomized to either (single dose) 25-mg (PEX010-25 group) or 1-mg (PPEX010-1 group) PEX010 in a 2:1 ratio. Brain and behavioral testing sessions will precede Psilocybin (PSI) dosing day by 24-48 hours and will follow PSI dosing by 1 week. After an initial 6 phases, participants will come into the lab to submit a urine screen 2x/week and to complete a short survey in order to collect data on drug use, MAT adherence, and mental health symptoms. The investigators hypothesize the PEX010-25 (vs. PEX010-1) group will have better clinical outcomes (e.g., lower average percent positive urine drug screens, more late relapses, higher MAT adherence). There are research follow ups every three months out to one year post dose.
Primary Outcome
Urine drug screen (UDS), percent positive illicit opioids (e.g., fentanyl) during the 8-week outpatient phase, calculated by taking number of positive detections by total number of opportunities to submit UDS (2 per week for 8 weeks equals 16 opportunities). This variable will be a single, continuous variable measured as a percentage. As well as self-reported drug use via TLFB.
Conditions Studied
Interventions
- DRUG Psilocybin
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-10-07 |
| Est. Completion | 2027-10 |
| Phase | Phase 2 |
What NCT06786325 shows while recruiting
NCT06786325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Psilocybin is the first listed.
NCT06786325 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06786325 about?
NCT06786325 is a clinical study titled "Wellcome Leap Psilocybin for OUD". Investigators will recruit 36 individuals on MAT for OUD for a double-blind, placebo-controlled design to determine whether PEX010 (25-mg/d) shows preliminary efficacy on neural correlates of neurocognition and on clinical outcomes. Participants will be randomized to either (single dose) 25-mg (PEX0...
What is the current status of trial NCT06786325?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2025-10-07. Estimated completion is 2027-10.
What conditions does trial NCT06786325 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT06786325?
The interventions under investigation include: Psilocybin (DRUG).
Who is sponsoring clinical trial NCT06786325?
This trial is sponsored by Anna Rose Childress, Ph.D., which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06786325 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06786325's enrollment target sits among peer trials
36 193rd of 257 higher than 63 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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